Standing Committee G

Mr. Alan Hurst

Human Tissue Bill

Clause 18 - Procedure on reconsideration

Question proposed, That the clause stand part of the Bill.

Stephen Ladyman: Earlier, the hon. Members for Oxford, West and Abingdon (Dr. Harris) and for South Cambridgeshire (Mr. Lansley) asked about the compatibility of the group of clauses on licensing with the European convention on human rights, particularly article 6 and the right to a fair trial. Therefore, I thought that it might be helpful if I spelled out why we believe that the Bill is compatible with article 6, and gave the Committee the opportunity to debate the matter before we proceed.
 Paragraph 11 of schedule 3 sets out the procedure for licensing decisions. The Human Tissue Authority, through the relevant inspectorate, will give prior notification of proposed decisions to the applicant, licence holder or designated individual, together with reasons, and the person to whom notice is given may make representations to the authority about the proposed decision. Under clause 16, the appellant may then require the authority to reconsider the decision. That reconsideration will be undertaken by an appeals committee of the authority, one or more of which it is required to maintain by clause 17 to carry out its obligations under clause 16 to reconsider decisions. The committee will consist of members of the authority—not fewer than five and with a quorum of three. To answer the point made by the hon. Member for South Cambridgeshire, it is to be expected that those members will not have been involved in the original decision. 
 The Human Tissue Authority, as a public authority, must act compatibly with the convention when carrying out its functions. The procedure on reconsideration is set out in clause 18. The appellant or his representative may attend before and be heard by the appeals committee. Under clause 19, a person aggrieved by a decision on reconsideration may appeal to the High Court on a point of law. I hope that that will satisfy the hon. Gentlemen who raised the issues. 
 Question put and agreed to. 
 Clause 18 ordered to stand part of the Bill. 
 Clauses 19 to 22 ordered to stand part of the Bill.

Column Number: 182Clause 23

Clause 23

Preparation of codes

Andrew Lansley: I beg to move amendment No. 85, in
clause 23, page 14, line 13, leave out 'may prepare' and insert
'shall prepare one or more'.

Joe Benton: With this it will be convenient to discuss the following:
 Amendment No. 14, in 
clause 23, page 14, line 13, after 'prepare', insert 'or approve'.

Andrew Lansley: We have discussed codes of practice from various viewpoints during previous debates, so I should like to deal with a number of specific issues relating to the preparation of such codes. The amendments are designed to explore two issues.
 First, the legislation says: 
 ''The authority may prepare codes of practice''. 
I understand that it is the intention that it will produce them. The ''may'' in this context appears because the codes are in the plural, therefore the wording is permissive as to the number of codes that the authority has to prepare. Representatives of a couple of bodies raised with me the concern that they were unclear on how the authority could proceed other than by preparing codes of practice, and that, therefore, it should be specified in the legislation that they shall do so. Of course, if we were to say ''shall prepare'' codes of practice, there would be a question of how many codes the authority was to prepare. Therefore, I have phrased the amendment slightly differently, because 
''shall prepare one or more'' 
codes of practice seems to be consistent with the intention of the Bill and a little clearer. 
 Amendment No. 14 would permit the authority to adopt codes of practice that have been prepared by other bodies. For example, the Royal College of Pathologists has its own guidelines for the conduct of post mortem examinations, and no doubt there are others of which I am not aware. The range of activities that has to be dealt with under subsection (2) is sufficiently wide that the measure will no doubt impinge on a range of bodies that have been involved in scrutinising and giving guidance. 
 It might be excessive for the authority not to be able simply to approve existing guidelines in order to issue a code of practice. If it were to do so, the provisions on consultation would have to be complied with in the same way because such guidelines would assume the formal status of a code of practice of the authority. However, it would be transparent that the authority was approving an existing code rather than, necessarily, starting from scratch. 
 The purpose of amendment No. 14 is to permit the authority to approve codes of practice that are prepared by other bodies. Although that may be done in relation to one or two issues, it does not mean that that will not be extended in future. If, for example, the authority wanted to take a more self-regulatory approach with the professions, it could permit some of the professional bodies to take responsibility for 
 preparing codes of practice and then, under the legislation, approve them. That possibility—not requirement—might commend itself and, in the spirit of future, flexibility would be advantageous. I hope that both those arguments commend themselves to the Committee.

Richard Taylor: I strongly support the amendments. The Minister was kind enough to provide me with a copy of the code of practice on families and post mortems, which is very recent—it was written in May 2003. It answers many of my questions; to be honest, it answers one question more satisfactorily than she did. It is vital that we have at least the reassurance that existing codes will be taken into account when new ones, if required, are constructed.
 The hon. Member for South Cambridgeshire mentioned the Royal College of Pathologists guidelines on autopsy practice. Those came out only in May 2002, and will certainly remove some of the almost ghoulish practice that some of us as young housemen and students were appalled to see carried out in the long-distant past. I strongly support the view that codes of practice introduced by the Human Tissue Authority should be built on some of the very satisfactory existing guidelines.

Rosie Winterton: I shall start by giving a little background. The Bill empowers the Human Tissue Authority to prepare and publish codes of practice, and sets down the matters with which it must deal through the codes. In bringing all those issues together under the Human Tissue Authority and ensuring that common principles are applied, our aim is to ensure a consistent approach to all matters relating to the keeping and use of human tissue that fall within the broad remit of the authority.
 Many of the codes are to be subject to approval by the Secretary of State and are to be laid before Parliament so that the process can be observed and overseen at the appropriate level. As the hon. Member for South Cambridgeshire set out and as the hon. Member for Wyre Forest (Dr. Taylor) remarked, amendment No. 14 envisages the authority receiving and approving codes that have been prepared elsewhere. However, it would be inappropriate for the codes to be approved by the authority and then approved again by the Secretary of State. 
 The hon. Member for South Cambridgeshire referred to the Royal College of Pathologists guidance on the conduct of post mortems. It would be perfectly acceptable for the royal college to have particular guidance available that it was appropriate to issue to its members. The Human Tissue Authority might use that as a basis for its own code of practice. However, it is not necessarily true that all the objectives would be identical. We would not expect the authority to take on board and approve a document as it stands without a period of consultation, consideration and reflection. However, we would expect it to look at such codes 
 from a slightly wider perspective. That would not stop the Royal College of Pathologists and other professional bodies considering whether they wish to give additional advice to their members. 
 The authority should take a common-sense approach. If guidance were available that could form a basis for the codes of practice, the authority would take that into consideration. We want the theme of its work to be consultation with others who are involved. It would be inappropriate for the authority almost to rubber-stamping something that had been put together by perhaps only one group without considering some of the wider implications. At the beginning of the process, we would want the authority to engage in wider consultation. A common-sense approach would obviously be adopted, and where good guidance was available, we would certainly expect it to be taken into consideration. 
 Amendment No. 85 would make it mandatory for the authority to prepare at least one code of practice, but we do not think that that is necessary. I draw the attention of the Committee to the structure of clause 23. The authority is empowered to prepare codes under subsection (1) and it is required to cover in those codes the matters set out in subsection (2). The authority would be unable to fulfil the statutory requirement in subsection (2) if it were not to prepare codes under subsection (1). 
 There is an important point to that. If we were to say in subsection (1) that the authority must prepare codes and to specify in subsection (2) what those codes should cover, one might suppose that subsection (2) represented an exhaustive list. Obviously, that is not our intention. We intend that the authority should cover the matters listed in subsection (2) but that it should be able to prepare codes on other matters within its remit as it sees fit. As time moves on—this relates to the discussion that we had this morning—the authority may need to give guidance in circumstances that we cannot anticipate today. In addition, a single code might cover both the storage and use of tissue from living patients, while another free-standing code might cover the conduct of anatomical examinations. As I said, all those matters are covered in subsection (2). Furthermore, to return again to this morning's discussion, the authority might have to give guidance on some aspect of public display or on arrangements for live transplant. Those are just some examples of how things might move on and of how we will need flexibility to deal with such developments. 
 I understand the intention behind the amendments, but the powers in subsection (1) and the specific requirements in subsection (2) set out the right understanding of what we should expect from the authority. They also send a clear signal that the authority can extend its guidance to cover all the activities that fall within its remit if it considers that appropriate. With that explanation, I hope that the hon. Member for South Cambridgeshire will withdraw the amendment.

Andrew Lansley: I am grateful to the Minister for her explanation. In particular, I am grateful to her for explaining that the discretion in subsection (1) will allow the authority to go beyond the matters with which it is required to deal under subsection (2) and that the amendment might have had the perverse effect of constraining the authority. It is helpful to explain that to the wider community.
 On amendment No. 14, the Minister seemed to be talking about pre-existing guidance or guidance volunteered by professional bodies. I am not sure whether she really covered the issue of the authority taking a self-regulatory approach by giving other bodies the responsibility for preparing codes of practice and consulting a wider group of stakeholders, rather than simply resting on its professional expertise. I hope that the Government will consider the issue to ensure that nothing in the Bill will prevent the authority from taking such an approach. There is a risk of that, which would be undesirable because co-regulatory and self-regulatory solutions should be sought wherever possible, particularly when one is dealing with technical, professional matters. With those caveats, however, I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn.

Richard Taylor: I beg to move amendment No. 151A, in
clause 23, page 14, line 14, after 'persons', insert 'requesting consent for and'.
 I realise that I am returning in a way to a discussion that we had a few days ago, when the hon. Member for Westbury (Dr. Murrison) underlined the fact that those who request consent are just as important, if not more so, than those who carry out the activity. The amendment would require the Human Tissue Authority to have codes for the requesting of consent as well as for the carrying out of activities. 
 The reason for raising the issue again is the extremely clear letter that I received at the weekend, which I am sure other members of the Committee also received, from Professor Peter Furness, who is a professor of diagnostic histopathology. He puts the points well: 
 ''I am concerned that debate on this Bill is emphasising the relatively small number of post mortem samples'' 
and does not adequately address the 
''many millions of specimens from living patients.'' 
He continues: 
 ''There seems to be an entirely appropriate consensus that to approach patients for consent long after a sample has been taken is neither practical nor desirable . . . It is also self-evident that clinicians cannot, at the time of sampling, predict which specimens will be valuable for teaching or research within the laboratory.'' 
Professor Furness goes on to provide evidence that clinical staff are unlikely to request adequate permission to allow pathologists and researchers to use spare, and in some cases, waste samples for the necessary work. I shall not quote his evidence because it is extensive, but it largely concerns the point that has already been raised, which is that the obtaining of consent can be so onerous that clinicians do not have time to go into the detail. 
 Professor Furness has an answer that may be too broad for the Government to accept, but which would at least solve the problem. He feels that the NHS should record the wishes of patients when they originally book in, which would mean that the many millions of blood samples—the bits that are left over—from patients with rare forms of leukaemia could, if needed, be used for research. The amendment is important and seeks to separate the askers of permission from those carrying out the work, and to require the Human Tissue Authority to bear that in mind when drawing up its codes of practice.

Andrew Lansley: I am grateful to the hon. Gentleman for raising the issues as he did. The amendment is not necessary in practice because, by definition, not only the activity itself but the consent needed for it will fall within the authority's remit. The giving of practical guidance on consent is already in the provisions.
 The hon. Gentleman makes an important point, however, which I have discussed with both Professor Furness and the BMA. Although we have touched on the issue before, it is worth noting that the BMA has shown considerable interest in the question of whether consent can be sought—clearly it can be legally—at non-stressful times. Can one have ethical discussions with patients that are not necessarily related to, as it were, the moment of decision? That could happen with a GP, before undertaking treatment or at the point of out-patient referral. Indeed, there could be a discussion with a GP about a range of possible circumstances. The question arises because the more one focuses on the activity itself, the less people are likely to have the opportunity to consider ethical issues that relate to themselves, their bodies, their willingness to donate material, the purposes for which they might do so and possible exceptions to doing so. 
 As we have said, as time goes on and we move towards the electronic patient record, the bureaucratic impediments to such a discussion giving rise to consent at particular moments when treatment occurs will progressively be reduced to the extent that the electronic patient record will, in the long term, be available to clinicians when they see or treat a patient. 
 We should arrive at the stage where such a discussion could enable all clinicians to have some pre-existing indication of a patient's willingness to provide consent at the point at which consent might be taken. They might, as we know, have to supplement that consent by checking with the family of a patient who was unconscious, incapacitated or dead, but the process might be more effective as time goes on. It will certainly be less burdensome to the clinical medical professions when dealing with patients. It may also be much less stressful for patients when they give consent. I have trespassed slightly to make that point again. The point was not confined to Professor Furness, but it has attracted attention. People are not sure that this is the way to go, but I am sure that they would not want the Bill to close off that possibility.

Evan Harris: The hon. Member for Wyre Forest has given us an opportunity to ask the Government how they
 believe consent obtained in such a way for surgical specimens will be dealt with. We are faced with a choice between consent forms and the need to recognise that research shows that they are not working in the NHS. The consent form should provide a box for ''any and all uses'' for research within reason, although that would still require a separate box for controversial areas of research so that people can conscientiously object without their tissue being used for all sorts of purposes, some of which they may disagree with on moral grounds.
 There are two categories of research. One is a specific research project, such as the breast cancer research unit seeking to obtain normal breast tissue following breast reduction operations, which Professor Furness mentioned in his letter. In my experience of serving on a research ethics committee, the bid for research funding, or at least the protocol, usually involves one of the researchers ensuring that the patient had provided adequate consent and that it is not relied on without a clinician—often named as an investigator—participating in the research and having the responsibility of checking it to ensure that it was good and proper. That is one situation where the onus is on specific researchers to check the consent, although I am not suggesting that consent can be implied in any way. 
 There is a separate problem, however, in that such tissue may then be stored and might be available for a future research study that is just as valuable, if not more so, than the current one. The question is then whether the consent given at the time for a project will be wide enough. One can handle that difficulty by ensuring that the original consent form covers those options for future research along the same lines. 
 The letter describes how so many consent forms were not done properly. That was regrettable, but I do not believe that it will be a general problem. There is, however, the broader problem of samples, taken generally during operations, which may be useful to a research project. I have always believed that patients should have the opportunity to give consent for blood samples, for example, to be taken. However, it is clear from the examples already given and from my experience as a busy junior doctor in a hospital that tick boxes are often not ticked if they are not vital to the clinical issue at hand. There is also the problem of the consent form not being sent with the specimen—a problem that is not solved by an enduring consent on an electronic patient record. That is a fundamental problem, regardless of where the consent is recorded. If the consent does not follow the specimen, the pathologist and the researchers are put in a difficult position. 
 I wonder to what extent the Minister, subject to consulting the Human Tissue Authority and its codes of practice, envisages implied consent being provided for in such a way. She has mentioned the assumption that placing posters in surgeries where blood is taken would be sufficient for implied consent; it could be 
 said, ''Your blood may be used for NHS research purposes. Please let the doctor, nurse or phlebotomist know if you object to that.'' 
 I am not sure that that is the right way to proceed, given the need for proper, informed consent for research activities. However, it would be helpful if the Minister would take the opportunity to respond. In many cases, there is implied consent for research uses. We also need to discuss, not necessarily in the context of the Bill, how to use clinical governance to improve the appalling return rates for consent forms, which poses a genuine threat to research. 
 There is one final area: tissue taken in an emergency. Again, I do not think that the fact that it is an emergency is an excuse for not providing for consent to be obtained, because that consent can be sought from the patient after the emergency. We have also discussed what happens when patients do not regain competence after being seen in an emergency. Significant issues are raised by the amendment, and by the question of how to obtain consent for research samples. I shall be interested to hear the Minister's response.

Rosie Winterton: The points that have been raised reflect some of our earlier discussions, not only in Committee but on Second Reading. This legislation will clarify what people can do in given circumstances. As has been said repeatedly, the difficulties that have been experienced in deciding whether particular tissue can be used have arisen from hesitancy and lack of clarity. The Bill is aimed at sorting that hat out.
 I return to the core of the issue: we expect—current General Medical Council and BMA guidelines are clear and are followed in the vast majority of cases—that consent should be obtained, as the hon. Member for Oxford, West and Abingdon said. It is not acceptable to extend the boundaries of the type of material or the things that tissue can be used for, and this Committee should not attempt to do so. It is for us to set a clear framework and for the Human Tissue Authority in its codes of practice to consider the issues and give guidance on communication with families, in the case of a deceased person, and with individuals if the tissue is from a living person. 
 Schedule 1, part 2 allows for activities that can be undertaken without specific consent. However, we do not envisage introducing a category of implied consent. That would be very difficult for us to do, and quite wrong. It would be stretching the boundaries of what we have already laid out in the Bill as to what is and is not acceptable. We have to be quite firm, and that is certainly the view that the Government will take.

Andrew Murrison: Does the Minister agree that offering information about implied consent in the way described by the hon. Member for Oxford, West and Abingdon, through leaflets in GPs' surgeries and so on, is acceptable only to certain people? It would disadvantage those for whom that form of information was not available.

Rosie Winterton: Yes. A lot of the distress and controversy that has been caused arose because there was an assumption that it was okay to do x, y and z, and people did not feel that it was right. We must be quite clear that there is a balance that medical ethics committees require when particular research is carried out. I certainly understand the BMA's interest in whether consent gained during a non-treatment discussion could be effective for future uses of tissue collected then or subsequently. That goes back to the point made by the hon. Member for Westbury: consent should be taken when the individual has sufficient information about what will be done with the tissue. It is important that the authority looks when considering its codes of practice at the different ways in which consent can be obtained. We cannot say that it will always be appropriate in every case.
 In terms of the codes of practice considered in clause 23, conditions for obtaining valid consent will vary considerably according to the circumstances of each individual case. It is our clear intention that the codes should include guidance on the many and various aspects of consent that will be relevant to activities within the remit of the authority. The amendment before us does not assist us in making that possible. 
 The provision at subsection (1) gives the authority power to prepare codes; subsection (2) states what those codes must cover. The amendment adds only to the aspect that empowers the authority to make codes; it does not bring any new obligation on the authority. It is clear that the codes will deal with matters of consent because the codes must provide for guidance on the removal, storage and use of tissue. Consent is the key element of the requirement of the Bill.

Evan Harris: I am glad that the Minister made that last remark. Although the hon. Member for South Cambridgeshire said that he felt that clause 11 or clause 23(2) tackled the issue of obtaining consent, it is only explicitly mentioned in the reference to
''communication with the family of the deceased'' 
in clause 23(2)(g) and (2)(e). Therefore, is the amendment valid? It draws out what the Minister has just said: the activities involved must include gaining consent.

Rosie Winterton: The hon. Gentleman is right. That point relates to clause 24(1), which refers to the obtaining of consent and the standards expected to be laid down for obtaining consent for the purposes of section 1. Effectively, that means that clause 24 deals with specific aspects of consent in relation to post mortem consent. The reason why that has been addressed in clause 24 is that the clause goes through the processes and the qualifying persons to whom the consent applies. As we have said, appropriate consent under the Bill applies to the appropriate person who can give consent.
 We certainly expect the codes of practice to address the obtaining of consent from those who are living and tissue that has been taken. That theme runs through the Bill as a whole. I accept to a certain extent what hon. Gentlemen are saying about the reference to obtaining consent in relation to a deceased person—
 the relevant wording is in clause 24. Given the provisions set out in clause 23, codes of practice will be issued by the authority on what will be appropriate in different circumstances. However, I am prepared to consider how the provisions may be interpreted to the effect that the authority would not issue codes of practice in the circumstances that have been described. That is certainly not what we expect, as it would be impossible for the authority to fulfil its duties, particularly given the references in paragraphs (h) and (i) to the removal of a sample from a human body and the storage of that sample, for example. It is difficult to see how any of those duties could be carried out without the authority issuing guidance on how to obtain consent in such circumstances. 
 The point is interesting and we shall consider whether it might be necessary to make specific references. However, we do not want to limit the authority or divide the different codes of practice, which would make it difficult to see the connections between them or the theme of obtaining consent that runs throughout. I shall consider the issue because I accept that the expectation that guidance on living patients would be issued might have been aroused by the fact that the Bill also deals with obtaining consent when a person is deceased. With that assurance, I hope that the hon. Member for Wyre Forest will withdraw the amendment.

Richard Taylor: After that, it would be churlish to do anything but withdraw the amendment. I am pleased that the Minister has responded so willingly and is prepared to take my comments on board. The problem is real: I can recall crossing out awkward bits on post mortem consent forms just for speed. However, given the Minister's response, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Andrew Lansley: I beg to move amendment No. 7, in
clause 23, page 15, line 12, at end add—
 '(7) In preparing a code of practice, the Authority shall have regard to any guidance published by the Better Regulation Task Force in relation to the best practice in conducting a consultation.'.
 In responding to a previous debate, the Minister said that the authority would have regard to guidance from the Better Regulation Task Force. However, as I said earlier, the authority is under no obligation to have regard to such guidance. The amendment would require guidance derived from the work of the Better Regulation Task Force to be considered when undertaking consultation. In some instances, the Cabinet Office may issue such guidance. 
 To give one example, in all but urgent cases one would clearly want the authority to respect the 12-week injunction on time for consultation, which is derived from the work of the Better Regulation Task Force. If the Government will not adopt the amendment—such provisions are not unknown in legislation covering other regulators—I would like them at least to clarify the mechanism by which the 
 authority will be required to have regard to best practice on consultation. I therefore hope that the Minister can expand a little on what is in the Bill.

Rosie Winterton: Although I cannot accept the amendment, I hope that I can clarify the position on following guidance, particularly from the Cabinet Office. As members of the Committee will understand, it is Government policy that consultation should follow Cabinet Office guidance on best practice, and we expect all arm's-length bodies to comply with that policy. However, it is not necessary to provide for such things in statute. Indeed, to take a simple example, we cannot be absolutely sure that the taskforce will last for ever, although it may, so it would be risky to mention it in statute.
 The place to set out our policy on the Human Tissue Authority will be the management statement, which will be drawn up by the authority and the Department of Health, and used to hold the authority accountable to Parliament through the Secretary of State. I can therefore reassure the hon. Gentleman that we will expect the authority to follow Cabinet Office guidance on consultation and that that will be made clear in the management statement. With that explanation, I hope that the hon. Gentleman will withdraw the amendment.

Andrew Lansley: I am grateful to the Minister for that; she has made an interesting point about how the proposals will work. I was not aware that that was the mechanism; indeed, schedule 2 does not refer to the management statement as distinct from the authority's financial arrangements, and it would be interesting, in due course, to hear a little more about how the arrangements will work.
 As far as I can see, the authority is not only at arm's length but statutorily free of obligations, unless they are set out in statute. Clearly, the management statement is an extra statutory provision, and I would be interested to hear whether it would be enforceable in relation to the authority. 
 I simply wanted to flag up those questions, to which we may return later. They have elicited at least one useful piece of information, and, on that basis, I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn. 
 Question proposed, That the clause stand part of the Bill.

Andrew Lansley: I want to ask one or two questions for the record. There is obviously a substantial relationship between the codes of practice and the activity of the NHS. Ministers will understand that point, not least because the explanatory notes set out some of the public sector financial and manpower consequences that flow from the Bill. The explanatory notes give a figure of about £2.7 million for resources and £300,000 for a central training budget. I am sure that many in the NHS are concerned to ensure that the resources for implementation and training will reflect
 requirements not only once the Bill is enacted. There are one-off costs even now that are associated with implementing the interim statement and introducing consent forms. It would be useful if the Minister could say something about how the Human Tissue Authority, in framing codes of practice, will reflect its understanding of the resource implications of the codes' requirements.
 Will the Minister state that the Department understands that implementation and training need to be properly resourced? There is, in addition, the issue of the extent to which the NHS complies. I would be the last to add to the burden of inspection and control, and the Bill is clearly designed to place a set of obligations directly on the trusts and on those who receive consent and undertake regulated activities. 
 There are many variables, such as the extent to which existing consent forms have been adopted in the NHS; that to which those who work with consent forms secure the appropriate consent at the appropriate time; and that to which, in line with the interim statement, bereavement counsellors are appointed in accident and emergency units. There will be concern in the NHS if its procedures are not in accordance with the Bill at the point at which the Bill comes into force. In theory, criminal penalties or severe consequences would flow from a failure to take proper procedures into account. Equally, if patients and their families feel that obligations are set out in the Bill but are not being complied with in practice in the NHS, they will suspect that some of our objectives have been undermined. 
 Many of our concerns are to do with the relationship between the codes of practice and NHS management activity. It is unfair for us to legislate—to impose codes of practice—and for the authority to promulgate codes based on the gold standard, if everybody in the NHS is then to discover that they have no resources, time or bereavement counsellors; they have not been given the consent forms in the appropriate manner; they have not had any opportunity to train, and so on. We cannot allow the strain of trying to reconcile such matters to fall wholly on a junior hospital doctor or NHS clinician who is trying to manage such things in the midst of addressing a range of other priorities. 
 I hope that the Minister can say something about the mechanisms. We have not previously discussed the matter, but we should do so, possibly on Third Reading. When we legislate, we must be clear about the processes by which activities will be managed, so that they will be acceptable in practice to the staff who have to live with them.

Evan Harris: I was interested to hear the hon. Gentleman's closing words, because I have identified some issues that we could well leave until Third Reading. We have both been requested by the Academy of Medical Sciences and others to raise the question, perhaps under the commencement clause or now of the time lag between the promulgation of the codes of practice—in order that people get to know them—and the implementation of criminal sanctions. If the Minister can pre-empt that, it would be
 appreciated by both of us, and by others who are concerned that there might be a big bang that will scare people and cause paralysis.
 The major concern about codes of practice is how they will impact on research using retained samples following surgery. I am raising the matter under clause stand part because of subsection (2)(d), which deals with 
''the definition of death for the purposes of this Act''. 
I thought that I had tabled a probing amendment on the issue; perhaps it was subsumed in our discussion on the new clause. 
 I declare an interest as a member of the BMA medical ethics committee. One thing that it has been concerned about has been the public's understanding of the definition of death, particularly because the terms ''brain death'' and ''brain-stem death'' are unhelpful. I hope that the Minister will agree that we need people to understand that death is death and that the death that we are talking about for the purposes of transplantation—when there is a beating-heart donation—is death confirmed by brain-stem tests. That is not death by observation of a non-beating heart and lack of respiration as well as pupilary fixed dilatation. Does the Minister consider that the reference pre-empts a code of practice that will serve as a way of educating everyone in the health service, particularly patients and relatives, that just because a heart is beating on a ventilator, death is death when confirmed by brain-stem testing?

Ian Gibson: Will the hon. Gentleman define how many ways we can record death? Do all doctors have different methods of recording death? Does a histopathologist have a different method from others? How many mechanisms of defining death are there?

Evan Harris: I look to my consultant colleague for correction on the matter, but generally when patients die in hospital, the junior doctor is called to verify—not certify—death by observation and examination of the body that demonstrates that life has expired. That will include monitoring the respiration and cardiac activity as well as the pupilary reflex.
 In the specific case of death while on a ventilator, death is verified by brain-stem testing. Sometimes that it difficult for people to understand and there have been some controversies about whether people whose death is confirmed by brain-stem testing are, in fact, dead. That can be damaging to the business and duty of the NHS to ensure that there is a transplantation service. Anything that can be done to make that point clearly, during this debate but mainly in a code of practice issued under subsection (2)(d), will be welcomed by those working in the service and by the BMA, which is particularly concerned about public understanding of the issue.

Richard Taylor: So that members of the Committee do not become worried, I wish to confirm that there are real safeguards in the rules for brain-stem death and particular exclusions in cases of people who have taken overdoses, when even some of the reflexes can be removed. I do not want people to be worried. As the
 hon. Member for Norwich, North (Dr. Gibson) said, it is left to pathologists to make the diagnosis, although I hope that physicians are good enough to make it before then.

Rosie Winterton: As for the points made by the hon. Member for South Cambridgeshire and the relationship between the Human Tissue Authority, the implementation that will be required by the NHS and those who work in it, we need to bear in mind a few issues. Over the next year, the shadow authority will be drawing up codes of practice in two ways. It will first build on best practice. The hon. Gentleman referred to gold standard. In many areas, that will conform with GMC and BMA guidelines. I do not believe therefore that, because the Bill and the codes of practice will bring such policies together and build on them, they will be new to most people in the NHS and those who work on the front line.
 At the same time, a common-sense approach will be taken. Before the penalties come into force, it will be important to have wide consultation as well as to build on best practice. Although the hon. Gentleman raises an important point, we must make sure that strings are not attached to the service. 
 In a sense, the safeguard is that the health service can implement what the authority draws up while it is in shadow form and puts into practice when it comes into being. Otherwise, we would be back where we were before, with a lack of public confidence in the system. Therefore, it is vital that the authority issues code of practice that can be implemented. 
 The hon. Gentleman asked about bereavement and other services. Funding has been included in allocations already made, so such services can be offered. As I have said, there will be consultation on the draft codes, and people will have ample opportunity to comment and contribute, and to prepare for the time when the authority comes into being. 
 With regard to the definition of death under subsection (2)(d), I hope that hon. Members will forgive me if I do not enter into the technicalities, as others are far more capable than I am. The hon. Member for Oxford, West and Abingdon was right that the amendment gives me an opportunity to clarify some extremely important aspects of transplantation, so that people understand the difference between heart-beating donations and those when there is no heart beat. The provision sets out the means by which the fact of death is determined. The chief medical officer has already asked the Academy of Medical Royal Colleges to review the current code, and the Human Tissue Authority will pursue the matter further when it is established in shadow form. 
 I hope that I have shown the Committee that the clause can be implemented in a way that does not shock those in the health service who currently implement guidance from the GMC and the BMA. 
 However, they will have an opportunity to comment on and contribute to the draft code of practice that the shadow authority will draw up. 
 Question put and agreed to. 
 Clause 23 ordered to stand part of the Bill.

Clause 24 - Provision with respect to consent

Rosie Winterton: I beg to move amendment No. 108, in
clause 24, page 15, line 28, at end insert—
'( ) grandparent or grandchild;'.

Joe Benton: With this it will be convenient to discuss the following:
 Amendment No. 11, in 
clause 24, page 15, line 28, at end insert— 
 '(ca) grandparent;'. 
Amendment No. 102, in 
clause 24, page 15, line 28, at end insert— 
 '(cb) grandchild;'. 
Government amendment No. 110. 
 Amendment No. 12, in 
clause 56, page 34, line 9, after first 'sister', insert 'grandparent'. 
Amendment No. 103, in 
clause 56, page 34, line 9, after first 'sister', insert 'grandchild'.

Rosie Winterton: I have good news. It is either ''Guilty, m'lud'' or well done to the Opposition for spotting the deliberate mistake in the Bill. I wanted to give them something to get their teeth into and to test whether they were awake. Indeed, they proved to be awake.
 We are grateful for having been alerted to the fact that we had inadvertently left out grandparents and grandchildren from the list of qualifying relations of a deceased person who can consent to the removal, storage and use of that deceased person's tissue for scheduled purposes where the deceased made no decision about that prior to death. We have tabled the amendments to cover that. The amendments to clauses 24 and 56 cover the hierarchy and the list of qualifying relationships. 
 It is appropriate to put grandparents and grandchildren on the same rank in the hierarchy, and after brother and sister, rather than on successive levels, as in the Opposition's proposals. That is simply because it is unlikely that both a grandparent and a grandchild of a person would be alive and able to give consent at the same time. Therefore, there is little point in ranking one above the other. 
 I hope that the hon. Member for South Cambridgeshire will not press his amendments and triumphantly welcome mine.

Andrew Lansley: We do indeed welcome the Government's acceptance of the point that we put to them, and we applaud their amendments Nos. 108 and 110. They go further than we had divined: the Government noticed that it is unlikely that any person would at the same time have grandparents and grandchildren in a qualifying relationship. Happily,
 we do not have to determine whether grandparents should stand higher in the hierarchy of qualifying relationships than grandchildren, although that had been our intention.
 We commend amendments Nos. 108 and 110 to the Committee.

Evan Harris: I share that welcome for this group of amendments. However, I may have missed something. I wish to make a point that has only just occurred to me. I thought that I might raise it now, although I accept that it is not a big issue because it might be possible to answer it immediately by directing me to the right place. At what age does a child or grandchild who might be quite young become old enough to qualify to give that consent? Is it the sort of consent that is referred to in the rest of the Bill—in other words, must they be capable of giving consent in the terms of the Gillick competence? If so, where is that provided for, or is there a different standard of age? I imagine that there will be sad occasions when a child is asked to give consent. I would be grateful for clarification on that.

Rosie Winterton: The same principle would be applied as that applied earlier in the Bill to consent to anatomical examination: the Gillick principle—the age of understanding as applied in that sense.
 Amendment agreed to.

Andrew Lansley: I beg to move amendment No. 21, in
clause 24, page 15, line 38, leave out subsection (7) and insert—
 '(7) If the relationship of each of two or more persons to the person concerned is accorded equal ranking in accordance with subsections (4) and (5), it will be necessary to obtain the consent of each of them if they are a spouse or partner, parent or child.
 (7A) In relation to qualifying relationships in paragraphs (4)(c) to (g), if two or more persons concerned who are accorded equal ranking do not agree as to whether consent should be given, it will be sufficient to obtain the consent of one, if there are two, or the majority of them if there are three or more.'.

Joe Benton: With this it will be convenient to discuss the following:
 Amendment No. 19, in 
clause 24, page 15, line 40, after 'sufficient', insert 
 ', except in relation to a spouse or partner,'. 
Amendment No. 20, in 
clause 24, page 15, line 40, at end insert— 
 '(7A) In relation to persons in a qualifying relationship under subsection (4)(a) or (b), it will be necessary to obtain the consent of each of them.'. 
Amendment No. 27, in 
clause 56, page 34, line 7, at end insert— 
 '(8A) Subsection (8) does not apply in relation to any person to whom paragraphs (b) to (f) of subsection (4) of section 24 applies.'.

Andrew Lansley: This debate might be a little more complex than the one about including grandparents and grandchildren.
 Subsection (7) states: 
 ''If the relationship of each of two or more persons to the person concerned is accorded equal highest ranking in accordance with subsections (4) and (5)''— 
with the qualifying relationship hierarchy that we have just started discussing—
''it is sufficient to obtain the consent of any of them.'' 
Therefore, if there were two parents in a qualifying relationship, it would be sufficient to obtain the consent of either of them. If there were several siblings, it would be sufficient to obtain the consent of any of those siblings. I must confess that when I read that I was surprised. It seemed that there was a risk of expressly contemplating, for example, that the consent of one parent would suffice even though there were objections from another parent. That did not seem consistent with best practice. 
 Amendment No. 21 would change the structure of subsection (7) so that it said: 
 ''If the relationship of each of two or more persons to the person concerned is accorded equal ranking in accordance with subsections (4) and (5), it will be necessary to obtain the consent of each of them if they are a spouse or partner, parent or child.'' 
The first question that occurred was whether one could have more than one spouse. The answer is no, but one could have more than one spouse or partner. Legally, one could have a spouse at the same time as having a partner under the terms of clause 56, which we shall come to discuss. Let us contemplate the unhappy set of circumstances in which consent was given by an estranged spouse, but was objected to by a partner. As a consequence of the amendment, one would have to obtain in such circumstances the consent of each of them rather than either of them. 
 There is also the question of number of children and siblings, and so on. Proposed subsection (7A) says: 
 ''In relation to qualifying relationships in paragraphs (4)(c) to (g)'', 
which is from siblings downwards on the list in subsection (4), 
''if two or more persons concerned who are accorded equal ranking do not agree as to whether consent should be given, it will be sufficient to obtain the consent of one, if there are two, or the majority of them if there are three or more.'' 
The drafting may be not absolutely happy, in that one cannot get a majority of four. No doubt that is why one has parliamentary counsel. However, the purpose of the amendment is to ensure that it is not enough just to find the consent of one person. The principle should be that when the qualifying relationship is very close—that is, it involves a spouse, partner, parent or child—they should all consent. When the relationships are less immediate, one should look for the majority view. 
 Amendment No. 19 would also amend subsection (7). If amendment No. 21 were not acceptable, amendment No. 19 would be a different route to entrenching the right of a spouse or partner to object. Amendment No. 20 would insert a new subsection. It would go along with amendment No. 19, because amendment No. 19 would take out the provision in subsection (7) that means that ''the consent of any'' of the spouse or partners would be sufficient. Amendment No. 20 would insert a proposed subsection (7A), which would mean that where a spouse or partner, parent or child is concerned, 
''it will be necessary to obtain the consent of each of them.'' 
Amendment No. 27 relates to clause 56. In the qualifying relationships under clause 24, we are talking about spouse or partner. We are not engaging in a definition of ''next of kin''; we are setting up structural 
 qualifying relationships. The Civil Partnerships Bill will, no doubt, give the House an opportunity to consider the issues surrounding the relationships between persons who are not blood relatives or legal spouses. Clause 56 needs, for the purposes of the Bill, to tell us what a partner is. 
 Clause 56(8) says: 
 ''For the purposes of this Act . . . a person is another's partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship.'' 
To say that the definition of partners is that they live as partners is a circular argument. One is a partner if one is a partner. The important phrase is ''enduring family relationship.'' 
 I do not want to get into a long discussion about civil partnerships, although I could—you would not be happy if I did, so Mr. Hurst. However, I think that the hon. Member for Oxford, West and Abingdon is with me when I say that this is known colloquially as a spinster sisters amendment. One cannot and should not be able to elevate somebody in the ranking by virtue of an enduring family relationship where an individual's relationship to the person in question is defined elsewhere in the qualifying relationship. 
 One could say that even though the spinster sister who is living as a partner in a household with the person in question is not the person who ranks highest in the list of qualifying relationships, they should still be treated as such. I am arguing that we should not take that view; the qualifying relationship should not permit that argument to be won, not least because of the difficulties that will ensue for the NHS if it has to become arbiter of disagreements. We must try to be as clear as we can. If somebody is lower down in the list of qualifying relationships but is a blood relative, they should not be able to be treated as if they were a partner. For this purpose, a partner is exclusive of people who are otherwise specified in the list of qualifying relationships. 
 Amendment No. 27 states: 
 ''Subsection (8) does not apply in relation to any person to whom paragraphs (b) to (f) of subsection (4) of section 24 applies.'' 
Paragraphs (b) to (f) refer to people who could be next of kin. I have left out paragraph (g)—''friend of longstanding''—as it is entirely possible that a friend of longstanding might well be the same type of person who qualifies as a partner. I am concentrating on the question of blood relatives. I admit that my point is arguable, and that if one qualifies as a partner, one ought to be able to move up the qualifying relationship ranking. For clarity and to make decision making more straightforward for the NHS, I propose that we exclude that possibility.

Evan Harris: It is appropriate to deal with the last issue first since it is fresh in our minds. In a typically thoughtful contribution, the hon. Member for South Cambridgeshire has drawn our attention to a problem.
 Usually when this issue is discussed in the context of civil partnerships, the hon. Gentleman's colleagues take the view that such partnerships should extend to elderly spinster sisters living together in the sort of 
 relationship that he has described. It is noteworthy that that can work both ways, and he has identified that that might be awkward for the NHS to interpret. If one accepts the view that the term ''partners'' can extend to those people who are co-dependent on each other and living together in an enduring family relationship, which might include spinster sisters—a terrible stereotype, but one that the hon. Gentleman's colleagues have used before—it is reasonable that they should be allowed to move up the chain, as it were. If one accepts the definition of ''partner'' as reasonable, it does not automatically follow that simply because it is difficult for the NHS to interpret, a partner should not have the same status as, for example, an estranged spouse. That could create as many problems as the hon. Gentleman wants to solve. 
 I do not know whether the problem of definition can be solved for the Government by their being a little clearer about what they mean in clause 56. Perhaps in a rather prissy way those who drafted the Bill have left the terminology a little vague, because they have not understood it to mean a sexual relationship or its equivalent. There may be reasons for that. The Government often use the term ''living together'' as analogous to married status or a spousal relationship. Because the drafters of the Bill have chosen not to go down that path, I presume that they will resist the amendment and could be defended in so doing, at least for such purposes. 
 I am grateful to the hon. Member for South Cambridgeshire for having explained the other three amendments. They are different approaches to the same issue. I ask the Government to think twice before necessarily accepting them in full. Let us take the situation of two parents of an adult, where they are the people who will need to make the decision. It would be reasonable for the permission of only one of them to be needed for the purposes of transplantation. 
 The Committee will not be surprised to hear that I believe that, generally speaking, when we can apply a default position—I would like consent to be defaulted to saving lives, but that is a debate for another day—in the event of a draw, the default position would come into play. The direct saving of life is a sufficiently strong motive to do that, as well as the additional motive of sparing the relatives later regret. 
 As I have previously stated, there is now research evidence, although it is limited, that many relatives who say no—for understandable reasons at the time of their maximum grief—come to regret doing so later. That does not apply to those with strong religious or personal beliefs opposing transplantation. From other research about why relatives say no, not least the potential donor audit, it emerges that these beliefs are not held by the majority of relatives who refuse consent, or are not the reasons given by the majority of those who refuse consent. When families who have refused permission later see television or newspaper stories about people who have been saved by transplantation, there is evidence that they feel regret. 
 That is why there is a good motivation for the default position in the case of transplantation—where there is such a strong positive outcome—to be one in which donation should occur. There is a difficulty, even under this system, when the person who refuses says that the relative in question did not want to be a donor, and the person who says yes claims never to have heard of this unregistered objection. This is why there may be merit in recording opt-outs, regardless of the system one uses. 
 Nevertheless, I would urge the Government to think carefully before accepting this amendment, certainly in respect of subsection (4)(b). We know that there are family disputes on this issue. The hon. Member for South Cambridgeshire has recognised the difficulty in gaining a majority of four or the unanimity of two. I think that this requirement will cause the loss of life, while not solving the disagreement within the family, but rather creating a further victim of that disagreement. 
 In the case of a spouse or partner, again I have sympathy with the hon. Member for South Cambridgeshire, because there is a difficulty with cases in which an estranged spouse, for example, is able to consent, thereby overruling the wishes of a current partner. I do not know how often that situation arises, or how often an estranged spouse might be present. Subsection (8)(c) refers to instances when it is not practicable to communicate with an estranged spouse. Because those circumstances would arise so infrequently, and the number of lives that could be lost for want of transplantation would be significant—one or greater—the Government should resist the amendment even in its strongest form, which is where it relates to subsection (8).

Harry Cohen: I do not think that that is likely to be a great rarity. If a man is on his deathbed, it may well be that his estranged wife will arrive and the partner could be there as well. In that case, there would be a problem relating to who has the final say-so.

Evan Harris: That is certainly possible, but we are talking about two different situations. For a heart-beating donation, there may have been a time in the intensive care unit for a gathering of the relatives. I am sceptical as to whether the situation will arise often where an estranged wife takes a different view and insists that it is worth losing the opportunity to respect the wishes of someone in a high qualifying relationship in the absence, or the presence, of an opt-in. There is also the problem that a donor registration card may be carried, which will happen in perhaps 20 per cent. of cases. Where there is a clear wish on the part of the person concerned and a draw between two people in the highest qualifying relationships, there is a danger that the amendment tabled by the hon. Member for South Cambridgeshire would mean that the person's wishes were trumped again.
 The Government would have my support in resisting the amendment, but in so doing I recognise that it has a valid point to make and demonstrates how difficult some of the discussions can be at someone's 
 bedside. In any event, we ought to congratulate the hon. Member for South Cambridgeshire on tabling the amendment.

Rosie Winterton: The discussion highlights some of the difficulties that we get into when we try to anticipate the various situations that may arise. I appreciate that the amendment tabled by the hon. Member for South Cambridgeshire is designed to provide for possible disagreement between relatives about what should happen to a loved one's tissue and organs after he or she had died. As the hon. Member for Oxford, West and Abingdon said, there is a danger that the amendment would reduce the amount of human tissue available for valuable uses.
 I want to return to the points raised by the hon. Member for Oxford, West and Abingdon because we have to be realistic about the practical difficulties. Amendments Nos. 19, 20 and 21 would make it more difficult to obtain consent in cases where several people were involved. For example, if donation for transplantation were envisaged, getting consent from all the children in a large family would probably not be worth trying. Where families are scattered, or where a person has an estranged spouse and a current partner, it would not be practical to address all those people when time is such an important factor in transplantation. 
 We discussed some of the issues earlier during our debate on the consent clauses, and the Bill states that the consent of only one person in each rank of the hierarchy of next of kin would make removal, storage and use of tissue from a deceased relative lawful. That is also true in the case of consent to medical treatment of a child, when the consent of only one parent is sufficient. However, the fact that it would be lawful to take tissue with the consent of one party does not make it obligatory. 
 I return to some of the points made by the hon. Member for Oxford, West and Abingdon. We must be realistic about what faces clinicians and professionals who are with bereaved relatives. Frankly, if there is a massive disagreement around someone's bedside, it is unlikely that the clinician will overrule the wishes of one person who may be in an incredibly distressed state because that person has a lower ranking than another. In reality, the professional concerned is not going to take a vote, and then say, ''Well, you rank higher than another person and therefore I'm going to overrule the other people.'' It is not conceivable that people would act in such a fashion. 
 Although we can make such provisions, I urge members of the Committee to bear in mind that in such situations people are dealing with bereaved, grieving relatives who may have their own problems at the time. This relates to our earlier discussion about presumed consent. The reality is that, as opposed to waving legislation in front of people, a judgment will be made about whether things are practical. At the time, a certain course of action just may not be appropriate.

Richard Taylor: I support the Minister. The code of practice, which we have already mentioned, states:
 ''If any of these object''— 
meaning siblings— 
''the post mortem should not be done''. 
I have done exactly as it says. I have faced the problem and, as the Minister said, it is not possible to argue the case and hold a vote at that time.

Rosie Winterton: I thank the hon. Gentleman for those comments. Overall, the framework that we have set out will assist people. However, it is up to the authority to issue guidance on how to deal with such situations through its codes of practice. It is difficult for us to envisage and include in the Bill ways of resolving those disputes. Such methods would not work in every situation.

Evan Harris: I have been listening carefully to the Minister, and I accept her point, as I did earlier in the discussions about what happens when there is a donor card and families object. One cannot use the organs if that would cause severe distress to a relative. However, we must accept that things can work both ways and that doctors already face one relative saying that they would be upset if organs were not taken, because that was the wish of the person concerned, and another having a mild objection but otherwise being upset about the death. I am talking about that sort of situation, not about gross distress. Even under my system of presumed consent, significant distress on the part of a relative would be sufficient reason not to use the organ.

Rosie Winterton: The point is whether we can legislate for every situation; it is difficult. The authority can issue guidance and codes of practice, but there will always be times when people make a decision based on individual circumstances. We must respect that, and understand that it will happen on some occasions. We must ensure that there is flexibility for those who deal with people in those difficult situations.
 I am grateful for the opportunity to clarify what we mean by tabling amendment No. 27. The definition of partner in clause 56(8) distinguishes partners as two persons living 
''as partners in an enduring family relationship.'' 
We are clear that the definition does not include siblings, half siblings and other relations, who may share households but do not live as partners in that way. Having given those explanations and reassurances, I hope that hon. Members will not press their amendments.

Andrew Lansley: I am grateful to the Minister for her response. Amendment No. 27 invites debate on the Civil Partnerships Bill. The definition of partner is ''partner''. The Minister says that I should not worry about that definition, because partner means partner and, therefore, does not mean something else. I shall not succumb to that temptation. Debate on the Civil Partnerships Bill will, no doubt, clarify the meaning of partner. It might be worth flagging up the fact that there will be a read-across to this Bill. I will make sure that my colleagues are aware of that. I am sure that the Minister will do the same for her colleagues in the Department for Constitutional Affairs.
 Debate on the other amendments was useful. I hope that others think so too. It illustrated the point very well. The Minister was right to suggest that we need to bear in mind that there is a distinction between what is legally required and what will be reflected in the code of practice. As she argued, it will be excessive to require—for legal purposes—consent to be obtained from each of the persons in the qualifying relationships. My example of an estranged spouse may create some difficulties legally. 
 However, we need to bear in mind that, even though the code of practice will set out how that might work in discussion and guide medical staff about dealing with families in a sensitive way, legislation—like contracts—is about facing up to where people do not agree and where circumstances are difficult. I accept that, if the obligations in obtaining consent are too great and the NHS does not comply with them, there is a greater risk of litigious relatives using the structure than there is of making the obligations involved in obtaining consent too lax, and causing distress leading to litigation from those whose objections have not been complied with. 
 In practice, the way that the code of practice is likely to work is going to make rare those circumstances where somebody in a qualifying relationship of a close kind, who would be distressed by the retention of organs, is ignored. Even if that does happen from time to time, it will clearly not be at the behest of the NHS. It is more likely to be at the behest of other relatives, in a stronger qualifying relationship, who perhaps overbear their relative's objections. Under those circumstances, the NHS would not be liable. It certainly will not be legally liable because it will have regard to the requirements of the law. 
 I therefore take the point that the Minister made about the risks and the importance of getting those distinctions right. We need to be sure that the code of practice does not simply repeat the legislation. It must go beyond the legislation to guide people accurately on the range of circumstances in which they might find themselves. They need to think through precisely the circumstances that we have been debating and how they should properly respond to them. On that basis, I take the Minister's point and I beg to ask leave to withdraw the amendment. 
 Amendment, by leave, withdrawn.

Evan Harris: I beg to move amendment No. 178, in
clause 24, page 16, line 3, at end insert—
 '(8A) Once appropriate consent under sections 2, 3 or 4 and this section has been given in relation to the body of a deceased person, a human body, relevant material from the body of a deceased person or relevant material from a human body for an activity specified in Schedule 1, such consent endures until—
(a) the person from whose body the relevant material came specifically revokes it in writing;
(b) where consent was given on behalf of a child, the child reaches 18 and specifically revokes it in writing; or
(c) the person who gave such consent specifically revokes it in writing.'.
 The amendment gives us the opportunity briefly to return to the question of enduring consent. We already covered it, en passant, when debating other parts of the Bill. The amendment would clarify that once consent had been given under sections (2), (3), or (4), and sometimes in respect of qualifying relationships, that consent would endure until it is specifically revoked as set out. It is meant to probe the Government to clarify whether that is necessary. I suspect that they will resist it on the basis that it is not, although the concern is whether it is right that someone in a higher qualifying relationship can revoke consent where material has been retained and is still being used. 
 We dealt with the issue of the child earlier, so I will not repeat the arguments. Hopefully, the purpose of the amendment is understood. Will the Minister clarify whether the Bill will allow material for which appropriate consent was given at the time to continue to be used for research until consent is revoked as I have suggested?

Andrew Murrison: The hon. Member for Oxford, West and Abingdon is right to say that the Minister will almost certainly say that the amendment is superfluous. Nevertheless, it is a good amendment because it seeks to probe some important issues.
 Although I do not disagree with the proposals, I simply question whether there is a need to specify ''in writing''. In general, that would of course be absolutely right, but there have been times when consent will have been obtained not in writing. Clause 2 deals with that. That would need to be reflected, as would the possibility that the person concerned might not be in a position to revoke that consent in writing. One could adapt provisions in clause 2 to cover that possibility. 
 My second question concerns Gillick competence in the amendment. The hon. Gentleman has specified a child attaining the age of 18. I wonder whether he would reflect on making the child attaining Gillick competence another hurdle beyond which a child might be able to countermand consent that had previously been given.

Rosie Winterton: The hon. Member for Oxford, West and Abingdon was right to predict that we feel that the amendment is unnecessary. However, it gives me the opportunity to give him the reassurance that he is seeking.
 We discussed this matter last week, but I should like to say again for the record that, where parents have given consent on behalf of children, one might expect that as those children grow up, the parents would let them know what had happened. We are clear that it will not be necessary for researchers to seek out young people at the age of 18 to check that they are content that material from their bodies should continue to be retained for research, for example. It will not be necessary either to return to adults, at intervals, to check that their consent remains—as long as it had been given properly in the first place. We strongly believe that people carrying out activities under the Bill are entitled to assume that consent endures until they have notice of revocation. 
 The hon. Member for Westbury made an important point about consent in writing. We have not specified the form that consent should take, except in the case of advance written consent for donation of a body, or material from it, for anatomical examination by dissection or for public display. It would therefore be odd to say that revocation of consent relating to any scheduled purpose should be in writing. 
 The form that consent takes in different circumstances will be dealt with as laid down in the code of practice on obtaining consent. The code will make it clear to the person giving consent that consent to storage, for example, may be for an indefinite period. Similarly, we would expect the code to cover the practical scope for withdrawing consent, and the ways of dealing with it. 
 There may be circumstances in which it would be good practice for the withdrawal of consent to be noted on a medical record rather than set down in writing by the person concerned. We want to ensure that the consent arrangements are practical, and that they do not place an undue burden on the NHS and certainly not on tissue banks or researchers.

Evan Harris: I do not think that I missed it, but I should be grateful if the Minister would clarify whether it will be possible for someone higher in the hierarchy of qualifying relationships to come along at a later date and pull rank, as it were, or does the Bill clearly state that it is the qualifying relationship at the time of consent, and that it is a one-off?

Rosie Winterton: I am sorry that I did not clarify the matter for the hon. Gentleman. The Bill refers to the appropriate relationship at the time when consent was given. It would not be possible for somebody to come along later and reverse it; otherwise incredibly complicated situations would arise. Having taken the opportunity to place on record those particular points, I hope that the hon. Gentleman will withdraw the amendment.

Evan Harris: I am grateful to the Minister for her response, and I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Question proposed, That the clause, as amended, stand part of the Bill.

Evan Harris: We may have indirectly covered my point earlier through the hon. Member for Westbury, but I may be wrong. I want to probe whether there is any provision for anyone to say—in the form of an advance directive—that they specifically do not want someone to have anything to do with consent arrangements for the use of their body for research or transplantation. How would that be interpreted in relation to the clause?
 If we are discussing protecting the autonomy of people from whom organs come, as the Bill should, I would hope that the Bill at least leaves open the scope for recognising advance directives. I cannot see 
 whether there is such an opportunity in the Bill. I do not have an amendment tabled and it may be hard to draft, but in clause 24(8) there is scope to include an additional provision that makes it clear that we recognise the autonomy of individuals to decide who makes that decision for them at a time of incapacity or after their death. 
 By not tabling an amendment, I have not given the Government notice, and I am sorry. We will probably need to return to the issue because I suspect that it is a talisman for wider issues surrounding advance directives.

Rosie Winterton: If an individual was worried that all the people in the qualifying relationship would do things with their body that they did not want to be done, they would have the option of nominating a representative who could make decisions. I also expect that if a person had left specific instructions, they would be taken into account. However, as I said, if there were a real fear, there is provision in the Bill for an individual to have a nominated representative whom they were confident would carry out their wishes.
 Question put and agreed to. 
 Clause 24, as amended, ordered to stand part of the Bill. 
 Clauses 25 and 26 ordered to stand part of the Bill.

Clause 27 - Possession of anatomical specimens away from licensed premises

Andrew Murrison: I beg to move amendment No. 104, in
clause 27, page 17, line 8, at end insert
'and
(iii) is transferring to or using the specimen for the purposes given in Part 1 of Schedule 1 in licensed premises.'.
 The amendment deals with a concern that has been raised with several members of the Committee by the Anatomical Society of Great Britain and Ireland, which is worried about the position that a designated person might find themselves in, particularly in relation to subordinates to whom work might be delegated on the designated person's behalf. The amendment would ensure that the subordinate complied with the law in a more direct way, rather than the responsibility being shouldered entirely by the designated person. It goes back to a theme that we discussed earlier, whereby it seems that a remote individual may be expected to shoulder a great deal of responsibility under the Bill. The amendment would put the onus firmly on a subordinate who is working under the direction, whether directly or indirectly, of a designated person. 
 Incidentally, the amendment would also make it easier to transfer specimens from licensed premises to, for example, a lecture theatre, where they would be used for a scheduled purpose, such as education. At present, there is a lack of clarity in the Bill about whether that is possible. A lecture theatre might not be 
 a licensed place, yet we can think of many reasons for transferring material from a licensed place to a medical school; for example, to instruct medical students.

Rosie Winterton: Subsection (2)(b) provides that a person is not committing an offence of possessing an anatomical specimen away from premises with an anatomy licence if he has the written authorisation of the designated individual and is using the specimen for the purpose so authorised.
 The amendment appears to add the further requirement that the specimen should be en route to other licensed premises or used for part 1 scheduled purposes in licensed premises. The problem with the amendment is that it would narrow down the circumstances in which anatomical specimens—for example, bodies or parts being used for anatomical examination—could be held away from licensed premises. It appears to be seeking to ensure that the authorisation that can be given by a designated individual for removing anatomical specimens from licensed premises is limited to transfer to other licensed premises and for their use for scheduled purposes. While that seems to be a further protective measure, I do not think that it is necessary because it could inhibit important uses of anatomical specimens. 
 The clause 27(1) offence of unauthorised possession of an anatomical specimen reflects the provisions of the Anatomy Act 1984. It is intended to ensure that no unauthorised or inappropriate use is made of bodies or parts that have been donated for anatomical examination. However, the licensing arrangements under the Bill are different from those in the 1984 Act. Licences under the Bill are premises based, whereas licences for possession of anatomical specimens under the 1984 Act are not. There are situations, as the hon. Member for Westbury highlighted, in which it is desirable for anatomical specimens to be away from licensed premises—for example, for teaching purposes in a lecture theatre that is not on licensed premises. It is therefore necessary for the Bill to enable that to happen without the lecturer in possession of the specimen being at risk of prosecution or requiring the premises to be licensed. 
 Responsibility for giving authorisation lies with the designated individual. That person would give specific authorisation to another person to remove the specimen for a stated purpose. He will be constrained in what he can authorise by the consent that has been given, but also by other regulatory requirements, including the code of practice and any licence conditions. That would be sufficient to allay any concerns that the designated individual may authorise possession of anatomical specimens for unsuitable purposes. 
 Within that framework, the designated individual should be able to consider what is appropriate. We have already said that we do not want the licensing requirements to be so burdensome that every location at which some tissue might be kept would need to be 
 licensed. Equally, a lecture theatre in that context would be unlikely to be part of premises in respect of which a licence would be in force. 
 Subsection (4) allows transportation to other licensed premises, or to other places where a specimen is to be used for education, training or research. We do, therefore, envisage some legitimate uses in non-licensed premises, just as we recognise that every single researcher cannot be required to be licensed in order to keep a few tissue samples. 
 However, in subsection (2) we seek to ensure that proper oversight is maintained of the taking of specimens to such locations, and that is exercised under the authority of the designated individual. In that way we achieve the degree of flexibility and control that will ensure that appropriate activities are not unduly constrained, but that there is regulatory oversight. In short, the effect that I think these amendments are trying to achieve already exists in clause 27, so I hope that the hon. Gentleman will withdraw his amendment.

Andrew Murrison: I am grateful to the Minister for describing in depth the position as she sees it. She is right because safeguards exist. The purpose of my amendment was to probe that. Nevertheless, it remains the concern of many who will be affected that the Bill will give them undue responsibility—hence my amendment. In view of the assurances that the Minister has given, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 27 ordered to stand part of the Bill. 
 Clause 28 ordered to stand part of the Bill.

Clause 29 - Prohibition of commercial dealings in human material

Evan Harris: I beg to move amendment No. 116, in
clause 29, page 18, line 39, after 'if', insert
'in England, Wales or Northern Ireland'.

Joe Benton: With this it will be convenient to discuss the following:
 Amendment No. 117, in 
clause 29, page 18, line 41, at end insert 
 'whether in England, Wales or Northern Ireland or elsewhere'. 
Amendment No. 118, in 
clause 29, page 18, line 43, at end insert 
 'whether in England, Wales or Northern Ireland or elsewhere'. 
Amendment No. 119, in 
clause 29, page 19, line 2, at end insert 
 'whether in England, Wales or Northern Ireland or elsewhere'. 
Amendment No. 120, in 
clause 29, page 19, line 5, at end insert 
 'whether in England, Wales or Northern Ireland or elsewhere'. 
Amendment No. 121, in 
clause 29, page 19, line 8, at end insert 
 'whether in England, Wales or Northern Ireland or elsewhere'. 
 Amendment No. 122, in 
clause 29, page 19, line 10, at end insert 
 'in England, Wales or Northern Ireland'.

Evan Harris: The purpose of this group of amendments is to probe the extent to which the offences in the clause would be offences geographically that existed in the Human Organ Transplants Act 1989. I accept that that may not be right, but it is what I understand to be the case. Without the amendments, the prohibition would seem to be restricted to the area of the United Kingdom to which the clause applies—England, Wales and Northern Ireland.
 Amendment No. 116 makes it clear that the person commits the offence in England, Wales or Northern Ireland, but amendments Nos. 117 to 122 add to various parts of the clause the words 
''whether in England, Wales or Northern Ireland or elsewhere''.

Andrew Lansley: The hon. Gentleman raises an interesting point, which I confess I had not noticed. The 1989 Act said at that point, ''in Great Britain''. Clearly, the amendments would have an extra-territorial application to England, Wales, Northern Ireland or elsewhere, elsewhere being anywhere. Did he consider using the words ''in Great Britain''? Is that the point that he is trying to make?

Evan Harris: No, the point that I am trying to make is that the Human Organ Transplants Act 1989 made it an offence for someone in Great Britain at that time—I believe that there is now separate provision for Scotland, but I am happy to be corrected as to extent of the Bill—to do some of those things anywhere in the world. Therefore, a person committed an offence if, as in subsection (1)(a), he
''gives or receives a reward for the supply of, or for an offer to supply, the body of a deceased person or any relevant bodily material'' 
anywhere in the world, even though he is committing the offence in this country. The provision may not be required any more, but it was suggested to me that the geographical area where the transactions that were being prohibited could take place was being restricted, by default, to England, Wales and Northern Ireland. 
 I shall not go through all the areas where my amendments make it clear that the provision applies elsewhere, but they can be seen at the end of lines 41 and 43 on page 18, and lines 2, 5, 8 and 10 on page 19. Therefore, I am probing whether there has been a specific change and, if there has, what the motivation and justification are for apparently restricting the provision. As I said, the clause may apply to offences committed anywhere in the world. In that case, it is not clear that the committing of the offence is restricted either. I should be grateful for clarification.

Andrew Murrison: I thought that it was clear and I am now extremely confused. Perhaps the Under-Secretary will be able to shed light where suddenly there is darkness.
 I do not understand the purpose of the hon. Gentleman's amendment. I thought that he was going to talk about materials, such as blood, that can be 
 traded internationally, and the fact that the Bill might make that more difficult. I, too, seek clarification, but for slightly different reasons from the hon. Gentleman.

Stephen Ladyman: Like the hon. Member for Westbury, darkness often falls over me when I listen to the hon. Member for Oxford, West and Abingdon. I think that I can give the hon. Member for Oxford, West and Abingdon the assurance that he needs, but let me say first that his amendments would leave the Bill as it is.
 Amendment No. 116 would limit the activities prohibited by clause 29 to those done in England, Wales or Northern Ireland. However, that is the effect of the clause in any event and is the extent of the Bill. Amendments Nos. 117 to 122 would provide that the supply of the human material to which the unlawful activity relates could take place anywhere in the world, which is also the effect of the clause. The offences that a person would commit are described in clause 29. If people advertise for material in England, they are committing an offence even though it may ultimately be supplied somewhere else in the world. Equally, a person might seek someone in England who was willing to supply material, but that offence would take place here, because it would be a prohibited activity. I hope that that provides the reassurance that the hon. Gentleman seeks. 
 I should like to bring to hon. Members' attention clause 4 of the Asylum and Immigration (Treatment of Claimants, etc.) Bill, which is currently before Parliament. That is also relevant because it introduces a new criminal offence of trafficking people into or out of the UK for the purpose of exploitation. A person commits the offence if he arranges for a person to enter or leave the UK to exploit them. The offence is also committed if a person has arranged travel to the UK knowing that the passenger has been brought into the UK to be exploited. Exploitation, in that case, would include organ removal. I hope that that provides sufficient reassurance for the hon. Gentleman.

Andrew Lansley: I understand the point that the Under-Secretary is making on geographical differentiation—I understood that that was so—but there is a consequent difference in terms of the penalties associated with the offence. Clause 29(4)(a) says that there would be
''on summary conviction . . . imprisonment for a term not exceeding 12 months'', 
which would presumably apply in England and Wales. However, clause 53 substitutes the words ''6 months'' for Northern Ireland and presumably, by extension, under the Human Organ Transplants Act that becomes three months in Scotland, because its regime continues to apply there. I wonder why the Under-Secretary thinks that it is reasonable for there to be three different penalties in different parts of the United Kingdom for what is effectively the same offence.

Stephen Ladyman: The hon. Gentleman is probably probing the effects of devolution. These are the narrow lanes down which we have to travel in a devolved constitution. I undertake to review the matter to ensure that everything is as consistent as it can be.

Andrew Lansley: As far as I can see, these are not devolved matters. I am probing not the effects of devolution, but the way we behave here in what he might regard as the devolved context.

Stephen Ladyman: I accept the hon. Gentleman's assurance that he is now a committed devolutionist and hope that the hon. Member for Oxford, West and Abingdon will withdraw his amendment.

Evan Harris: I am rather wounded by the Under-Secretary's response—he was uncharacteristically churlish in responding to a briefly put probing amendment. If he wants non-probing amendments to be taken to a Division and proposed at length, I am sure that many of us on the Opposition Benches could meet that requirement. He should not allow the lateness of the day to make him so grumpy. Clearly, he is satisfied that he understands his Bill and I am delighted that he does. That is the minimum that we expect from a Under-Secretary who is paid to do such a job. However, people are asking whether the extent of the measure in respect of from where the trafficking is being done is different because of the way in which the provision is worded, so it is legitimate for us to probe such matters. I am grateful that, in an indirect way, the Under-Secretary has said that we need not worry. We have heard him say that before, but we can be reassured in this case. I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Andrew Lansley: I beg to move amendment No. 152, in
clause 29, page 19, line 21, at end insert—
'(c) he pays an intermediary to locate and obtain relevant bodily material for purposes under paragraphs 3 and 7 of Schedule 1, providing that this shall not apply in relation to offering or giving of any reward that relates specifically to relevant bodily material or to the body of a deceased person.'.

Joe Benton: With this it will be convenient to discuss the following:
 Amendment No. 8, in 
clause 29, page 19, line 47, at end insert— 
 '(c) any expenses incurred in adding value to, or increasing the utility of, relevant material.'. 
Amendment No. 153, in 
clause 29, page 20, line 16, at end add— 
 'that relates specifically to relevant bodily material or to the body of a deceased person'. 
Amendment No. 154, in 
clause 29, page 20, line 16, at end add— 
 '(11) References in subsections (1) and (2) to reward, in relation to the supply of the body of a deceased person or the supply of relevant bodily material, do not include payment in money or money's worth for services provided in relation to— 
 (a) preserving the body of a deceased person supplied or the relevant bodily material supplied for use in a purpose specified in Schedule 1; 
 (b) preparing the body of a deceased person supplied or the relevant bodily material supplied for use in a purpose specified in Schedule 1; or 
 (c) generating data relating to the body of a deceased person supplied or to the relevant bodily material supplied in carrying out a purpose specified in Schedule 1.'.

Andrew Lansley: The amendments are not all designed for the same purpose, but they are all derived from the same worry. Members of the Committee will have observed that, under clause 29, we are transferring what has hitherto been a regime designed to stop commercial dealing in organs for transplant into an appropriate regime for the prohibition of commercial dealing in human material. To do that, we are having to consider a range of currently legitimate purposes along with the risks associated with rendering them illegal. The range of activities associated with all the scheduled purposes and the kinds of tissues that are used go much wider and are much more difficult to constrain than the matter of organs for transplantation.
 Although there are differences between the Human Organ Transplants Act regime and clause 29, the new regime will be based on that. The purpose of the amendments is to examine to what extent the current structure of clause 29, in practice, will avoid criminalising current legitimate and ethical activity. I shall start with amendment No. 152 because, on the face of it, there is a problem associated with what is currently common practice, which is that of organisations providing some form of seek-and-supply or brokerage service to make difficult to obtain or rare specimens accessible for research. That can be based on a prospective collection basis or presumably from pre-existing tissue banks. The services are provided for commercial gain and are currently regarded as ethically acceptable. It seems that they would be prohibited under clause 29. 
 I raise the matter partly because of representations from the biotechnology industry, but last night I discussed the issue with scientists who work for Breakthrough Breast Cancer next to Royal Marsden hospital in Chelsea. They said that one of the things they do to obtain the necessary tissues is to procure them from commercial sources. Obviously, they would like to do so at as least a cost as possible. If they do not have to pay anything other than the costs associated with preparing, preserving, storing, transporting and adding utility to the tissue samples, and are not paying for the material per se, that is how they wish the position to be and that is the position as we wish it to be. It also seems to be the position that the biotechnology industry wishes it to be. 
 The question is whether we have covered accurately the definitions of what is accepted under subsection (3), which deals with particular activities or categories that are not to be regarded as committing an offence if they are undertaken. Amendment No. 152 is about intermediaries who locate and obtain relevant bodily material. Those activities are currently legitimate, but should they be included in subsection (3), so as not to create a criminal offence out of them? Brokering is clearly not an expense incurred in transporting, removing, preparing, preserving or storing. 
4.45 pm
 We are dealing with the application of criminal sanctions to intermediaries. They provide a vital service and gain access to sufficient numbers of specimens for meaningful studies, including those of scientists engaged in important research. 
 Amendment No. 8 deals with expenses. Subsection (7) excludes expenses but it does not exclude the ''expenses incurred'' when adding value. Preparing, preserving and storing may be how value is added. We must be clear that it would in practice include freezing tissue for transportation, preparing histological sections, undertaking pathological review, embedding tissue in paraffin blocks, generating data from tissue and obtaining and providing that data, which adds utility for those people who might wish to obtain it for research purposes. 
 Some of those activities may be covered by the definitions is subsection (7). Others may not. The amendment seeks to make it clear whether expenses incurred in adding value or increasing the utility of relevant material would not be regarded as trafficking in human material. 
 Amendment No. 153 reinforces the previous point by defining reward as the description of financial or other material advantage 
''that relates specifically to relevant bodily material or the body of a deceased person.'' 
It focuses the criminal offence upon the question of whether reward is being sought or given in relation to the human material or the body, as distinct from the processes or the added value that may result from any activity associated with it. 
 Amendment No. 154 tries to clarify the position on payment of services. I hope that preserving and preparing the body—proposed paragraphs (a) and (b)—are covered by subsection (7), but generating data relating to the body of a deceased person may not be. The amendment sought further clarification about the activities, currently legal and ethically acceptable, that will be criminalised or are at risk of being criminalised by clause 29. 
 I hope that the Under-Secretary understands the direction from which we are approaching the matter. We are trying to arrive at what I hope are shared purposes, although from the first time I read the clause, I was worried that a measure that had first been drafted for a narrower purpose was being extended to a much wider range of activities. 
 The risk we run of criminalising existing legal activities depends entirely on whether the exceptions and definitions included are able to clarify what is acceptable. Focusing on the question of not obtaining reward for the human material or the body seems to be at the heart of the matter. I hope that the Under-Secretary will be able to assist us.

Stephen Ladyman: There is agreement across the board about what the clause should achieve: there should be no financial gain from trafficking in human body parts. By transposing clause 29 from the Human Organ Transplants Act 1989, we thought that we were achieving those objectives and allowing for
 recompense for expenses incurred in such dealings. Having said that, we recognise that the representatives of the biotechnology industry have serious reservations about whether what we have attempted to do has been achieved in these provisions. The hon. Gentleman has restated those reservations. If he is prepared to withdraw his amendment, I am prepared to ensure that we review the clause thoroughly, and if necessary bring back some clarifying amendments on Report.

Andrew Lansley: The hour makes us even more grateful to the Under-Secretary for his willingness to do that. I am grateful to the Committee for bearing with me while I set out the concerns. I think that I have covered them. I hope that we will have a productive discussion when it comes to ensuring that our purposes are met but legitimate activity is not criminalised. I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Andrew Murrison: I beg to move amendment No. 107, in
clause 29, page 20, line 8, after 'hair', insert ', teeth'.
 This is very simple. The materials excepted from the clause are listed on page 20. There has been some debate about the nature of the tissues listed in various forms in the Bill. The purpose of my amendment is to add the word ''teeth'' to subsection (9)(c). The debate so far seems to have centred on cells. We had an interesting discussion at an earlier stage of the Committee about how that extended to hair, which does contain cellular material, in part, even though most of us think of it as a dead material that is acellular. We are in an area that is fraught with definitional difficulties and it strikes me that there is no particularly good reason for excluding teeth from subsection (9)(c). I would be grateful if the Under-Secretary considered that matter. 
 While my hon. Friend the Member for South Cambridgeshire was on his feet, it occurred to me that a number of materials can be, and probably still are, used commercially that could be excepted in some way. I was thinking in particular of placentas, which used to be traded commercially. I suspect that they still are traded in one way or another for the beneficial uses to which they can be put in research and for the materials and chemicals that can be extracted from them. One might include placentas in the list of exceptions, but I will leave that aside and focus on my amendment, which would include teeth with hair and nail.

Stephen Ladyman: This is commonly known as the tooth fairy amendment. Teeth have value in research and education, so it is appropriate that they are covered in the Bill. However, I can give the hon. Gentleman, and any other Committee members with children, confidence that we do not intend to use the Bill to prosecute the tooth fairy. Members of the Government will not be hiding outside bedrooms to ensure that no inappropriate activities with teeth take place. The only thing I would encourage the Human Tissue Authority to consider is including teeth in good practice guidance, so that my daughter will not be able
 to insist on getting enough money from the tooth fairy to buy an S Club 7 CD every time she loses one of her milk teeth.
 It is right that teeth are included in the Bill. I ask the hon. Gentleman to withdraw his amendment.

Andrew Murrison: After such an eloquent description of the activities of the tooth fairy, and knowing full well what the Under-Secretary means, I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Evan Harris: I beg to move amendment No. 123, in
clause 29, page 20, line 9, leave out paragraph (d).
 The purpose of the amendment is to get the Government to put on the record what they understand by the exception provided for in subsection (9)(d), and to specify what sort of things it covers. In much of the Bill, that is not clear and darkness descends on many of those seeking to read and understand it. It is not always clear, and perhaps the Under-Secretary will take this to explain what is meant by the words 
''material which is the subject of property because of an application of human skill.'' 
Will the Under-Secretary give the examples of that, which I know he has?

Andrew Murrison: I join the hon. Member for Oxford, West and Abingdon in being slightly bewildered by what is meant by ''human skill''. It seems to me that that term is quantitative as well as qualitative. We can all think of things that require an enormous amount of human skill. I suppose that mummies are the quintessential example of that, although they are excluded from the Bill. There are other examples, such as simple embalming, which involve a certain amount of skill but I do not suppose that they are on the Under-Secretary's mind. Like the hon. Member for Oxford, West and Abingdon, I seek clarification of the matter.

Stephen Ladyman: The proposals for new legislation on human organs and tissue that were issued in September 2003 by the chief medical officers for England and Wales said that the new legislation should incorporate the principle that the human body and its parts should not give rise to financial gain. The clause gives effect to that underlying principle subject to certain exceptions, and one such exception is material that is the subject of property because of the application of human skill.
 That exception reflects the current legal position as determined by case law, that there is no property in the human body or its parts, so they cannot be bought or sold, except where human skill has been applied. The Bill recognises, but does not change, that legal position; the Bill leaves the position as it is now. I would rather, at this time of the evening, avoid citing some of the cases to which the hon. Member for Oxford, West and Abingdon refers, so I encourage him to read about them for himself.

Evan Harris: The Under-Secretary's comments are understandable. I know that there has been a long-standing provision in case law that there is no property in human bodies, with the given exception. The problem is that it is not entirely clear what sort of things the exception covers. I suppose that the answer to those who wondered whether they might fall foul of the law in that respect is to go and read the case law or get a lawyer. I seek the Under-Secretary's help.

Stephen Ladyman: It would be appropriate, given the best practice guidelines, to give people that help, which will explain the issue. There are examples in case law, such as the 1998 case where the value of certain body parts was increased extensively by a dissection process that took many hours. The courts found that human skill had been applied and that the value of those parts had increased as a result of that human skill. Simply dipping the parts in formaldehyde would not, in my view, constitute the application of human skill, which is what the Bill provides for.

Evan Harris: The Bill therefore leaves unclear the qualitative and quantitative—in the Under-Secretary's example—extent to which the exemption applies. Peril is created for those in the business, and it seems a conscious decision of Government not to use statute law to define the issue any further, and to continue with the status quo.

Stephen Ladyman: If it helps us make progress, I am happy to consider the clause again.

Evan Harris: I am grateful, and I am keen to make progress as well, given the time. In light of that—as I was about to say in any event—I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn.

Andrew Lansley: I beg to move amendment No. 155, in
clause 29, page 20, line 10, at end insert—
'(e) material necessary for the conduct of clinical trials of pharmaceutical preparations or products (including diagnostics and medical devices).'.
 The amendment relates to another part of the clause on which we seek the Under-Secretary's help, either in explaining or considering it. The point has to do with the conduct of clinical trials. If one were simply consenting patients for the trial itself, the immediate response of the patient to treatment would not really be affected. If we are talking about the sort of clinical trial that involves the collection of tissue samples and subsequent examination, that might involve the tissues being transferred from a number of centres to some kind of co-ordinating centre that provides a service in relation to the clinical trial, perhaps on a commercial basis. It might involve research companies, charities and the NHS itself. The Under-Secretary is only too familiar with how that works. 
 The question is how that is to be dealt with. Does it follow that that will be illegal, because the taking of the tissue samples must be covered by the consents making it lawful under the legislation, and therefore must be regulated by the authority and licensed? Do we need to 
 be concerned that clinical trials of that kind will not necessarily fall within such definitions, and therefore need to be excepted from the Bill? I suppose there are one or two aspects of clinical trials themselves, such as advertising for people to participate in them or the process of payment for the transfer of tissues between those in them, that raise exactly the kind of issues that we have debated under amendment No. 152. They are not within the regulatory structure of the authority for giving licensing premises, licensing individuals and regulating consent for the activities themselves, but go beyond that into commercial dealing. As I understand it, the authority cannot make commercial dealing legal; it has to regulate what it regulates, and commercial dealing, outwith what it regulates, is illegal. There may be a risk, particularly where advertising is concerned, of it being rendered illegal but perhaps the Under-Secretary will help us on that matter, too.

Stephen Ladyman: We believe that the Bill is appropriate as it stands, but having said that, the hon. Gentleman is right to say that these are complex and important matters. We certainly would not want any wording to interfere in the conduct of clinical trials. If the hon. Gentleman is prepared to withdraw his amendment, I am prepared to ensure that we review both the wording of the clause in its entirety, and the impact of the hon. Gentleman's point, before Report.

Andrew Lansley: I am grateful to the Under-Secretary, and I beg to ask leave to withdraw the amendment.
 Amendment, by leave, withdrawn. 
 Clause 29 ordered to stand part of the Bill. 
Further consideration adjourned.—[Joan Ryan.] 
 Adjourned accordingly at three minutes past Five o'clock till Thursday 5 February at ten minutes past Nine o'clock.